At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 381 enrolled
Drug / intervention
Mitiperstat (AZD4831) +1 moredrug
Likely dose
Mitiperstat (AZD4831) oral dosage once dailyAI-extracted
Key inclusion· 6
- ✓Confirmed diagnosis of moderate to severe COPD
- ✓High risk of exacerbations defined by ≥1 moderate/severe exacerbation in prior 24 months, OR frequent productive cough, OR post-bronchodilator FEV1 <50% predicted
- ✓Age 40-80 years at consent
- ✓Current or ex-smoker with ≥10 pack-year tobacco history
Key exclusion· 4
- ✕Current asthma diagnosis or past asthma persisting beyond age 25
- ✕Clinically important pulmonary disease other than COPD
- ✕Clinically significant infection (viral, bacterial, or fungal requiring systemic therapy >7 days) within 4 weeks before Day 1, or suspected infection at dosing
- ✕Any clinically relevant abnormal findings on physical exam, laboratory testing, haematology, coagulation, serum chemistry, urinalysis, or chest CT that may compromise safety or interfere with study evaluation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating Mitiperstat (AZD4831) and Placebo for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 381 participants across 101 sites in 14 countries.
Detailed Summary
This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartNov 2022
Primary CompletionAug 2024
TodayJul 2026
First PostedAug 9, 2022
Enrollment StartNov 14, 2022
Primary CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.9 years ago
Interventions
Mitiperstat (AZD4831)drug
Oral dosage, once daily.
Placeboother
Oral dosage, once daily.